GEMINI 1 - A Phase III multicenter trial evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine (study drugs) compared to dolutegravir plus tenofovir/emtricitabine in HIV-1

Infection, HIV
Dr. Daniel Skiest

Baystate Medical Center, 759 Chestnut Street, Springfield, MA

The purpose of this study is to compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily to the DTG plus Tenofovir [TDF]/Emtricitabine [FTC] fixed dose combination [FDC] administered once daily in human immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC.

1. Must be an HIV 1 infected adult ≥ 18 years of age

2. Subject should be antiretroviral naïve (defined as ≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection)

Dr. Daniel Skiest